COMPOUND (INN): HOE490O - GLIMEPIRIDE / METFORMIN HCl (Amaryl® M)0 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.

• Status: Withdrawn
• Trial end date: 2015-12-01

Summary

The purpose of this study is to assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.

• Phase: Phase 1

Details

• Lead Sponsor: Pharmaceutical Research Unit, Jordan
• Collaborators: Sanofi; Sanofi-aventis Liban SAL
• Treatments: Glimepiride; Metformin